title: First clinical experience with the new four-pole standard connector for high-voltage ICD leads. Early results of a multicenter comparison with conventional implant outcomes.
abstract: OBJECTIVE
  A new four-pole connector system (DF-4) for transvenous high-voltage implantable cardioverter defibrillators (ICD) is currently available in clinical practice. However, no clinical data demonstrating the safety and effectiveness of this complex electromechanical design is available. This study aims to test the safety and effectiveness of this newly designed system compared to the conventional DF-1 leads.
  
  
  METHODS
  During a 3-year period, 351 consecutive patients were implanted with DF-4 leads as part of an ICD or ICD-cardiac resynchronization therapy system. Patients were matched for age, sex, and follow-up with 154 patients implanted with a standard DF-1 lead. The primary outcome of the study was defibrillation lead failure, defined as the need for lead removal or capping. Operative, electrical, and safety data were obtained at implant and during postoperative follow-up.
  
  
  RESULTS
  Implantation success rate in both groups was 100 %. A trend towards shorter procedure time was observed in the DF-4 group but the difference did not reach statistical significance. Handling characteristics of the DF-4 leads were graded better than those of DF-1 models. During a total follow-up of 8,130.5 lead-months, there were nine ICD-lead failures (four system erosion/infections and five electrical lead dysfunctions). The overall incidence of electrical lead failure was 0.64 vs. 0.97 per 100 lead-years, for DF-4 and DF-1 leads, respectively (P = 0.2).
  
  
  CONCLUSIONS
  This multi-center experience provides strong evidence that the feasibility and safety of this novel technology compare favorably with those of the conventional DF-1 leads.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University of Rome "Tor Vergata", Viale Oxford, 81, 00133, Rome, Italy, forleo@me.com.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Forleo
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.forename: Massimo
authors.initials: M
authors.lastname: Mantica
authors.forename: Germana
authors.initials: G
authors.lastname: Panattoni
authors.forename: Matteo
authors.initials: M
authors.lastname: Santamaria
authors.forename: Quintino
authors.initials: Q
authors.lastname: Parisi
authors.forename: Domenico
authors.initials: D
authors.lastname: Sergi
authors.forename: Lida P
authors.initials: LP
authors.lastname: Papavasileiou
authors.forename: Luca
authors.initials: L
authors.lastname: Santini
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D004869:Equipment Safety / Q000706:statistics & numerical data; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D038622:Internationality; D008297:Male; D055617:Micro-Electrical-Mechanical Systems / Q000295:instrumentation*; D010865:Pilot Projects; D015995:Prevalence; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome